Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings

Boston Scientific

Status: Completed

Conditions: Stone Clearance

Treatments: Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber

Study type: Interventional

Funder types: Industry

Identifiers

NCT02683993

LUM-SBU-VP-15-01

Details and patient eligibility

About

Twenty (20) subjects presenting with a renal stone and candidates for FURS (flexible ureteroscopic renal surgery) will undergo a single FURS procedure for a kidney stone as part of the study, using the study device. These subjects will be randomized into stone breaking treatment or stone dusting.

Full description

This is a randomized, two-arm, prospective, single center study. Subjects will undergo a single flexible ureteroscopic renal surgery (FURS) procedure for a kidney stone as part of this study, using the study device, and will be treated as randomized to either stone breaking treatment or stone dusting treatment. Follow up visits are scheduled for the day of release from the hospital and at 1 month post procedure. Additional treatment sessions, if required, will be at the discretion of the investigator, as part of the site standard of practice. Additional treatment sessions will not be included in this study.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject will be older than 18 years of age

2. Subject was diagnosed with renal calculi meeting the following criteria:

   • Largest stone measures no more than 2cm on a single diameter and is no less than 0.8cm as defined by X-ray or CT.
   • Accumulative stone burden (addition of all stone diameters) is no more than 2.5cm.

3. Subject is a candidate for FURS procedure

4. Subject is willing and has signed the Informed Consent Form

Exclusion criteria

1. Subject has undergone a previous treatment for stones in the same kidney
2. Subject requires another, concomitant procedure, other than FURS, to be performed during this treatment session.
3. Female subject is pregnant
4. Concomitant anticoagulant medication that cannot be suspended during surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Stone breaking

Experimental group

Description:

Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.

Treatment:

Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber

Stone dusting

Experimental group

Description:

Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.

Treatment:

Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber